LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K113647
    Device Name
    DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM
    Manufacturer
    SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
    Date Cleared
    2011-12-16

    (4 days)

    Product Code
    IYN,ITX,IYO
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K103583,K103677,K101236,K110199,K101757,K112596,K063085,K102256
    Why did this record match?
    Reference Devices :

    K103583, K103677, K101236, K110199, K101757, K112596, K063085, K102256

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel and urology exams.

    Device Description

    DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, CW mode, Color-Mode, Color M-Mode, Power/Dirpower Mode, TDI mode, 4D mode or the combined mode (i.e. B/M-Mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 3 MHz to 10.0 MHz.

    AI/ML Overview

    The provided text is a 510(k) summary for the Shenzhen Mindray Bio-medical Electronics Co., LTD DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to predicate devices and adherence to medical safety standards rather than establishing new performance criteria through clinical studies.

    Therefore, the document does NOT contain information regarding:

    • Specific acceptance criteria framed as quantitative metrics (e.g., sensitivity, specificity, accuracy).
    • Details of a study proving the device meets acceptance criteria in terms of clinical performance.
    • Sample sizes used for test or training sets for an AI/algorithm.
    • Data provenance, number or qualifications of experts, or adjudication methods for establishing ground truth related to clinical performance.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for human readers with/without AI assistance.
    • Standalone algorithm performance studies.
    • The type of ground truth used as it relates to clinical performance studies.
    • The sample size for the training set or how ground truth was established for a training set.

    The document primarily outlines the device's technical specifications, intended uses, and lists applicable safety and electrical standards it conforms to. It states that the device has been evaluated for "acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety" and found to conform with applicable medical safety standards.

    However, based on the provided text, I can infer the "acceptance criteria" and "study" in a regulatory context, which is demonstrating substantial equivalence to predicate devices and compliance with recognized standards.

    Here's a breakdown of what can be extracted based on that understanding:

    1. Table of "Acceptance Criteria" and "Reported Device Performance":

    In the context of a 510(k) submission for a diagnostic ultrasound system like this, the "acceptance criteria" are not reported as specific performance metrics (like sensitivity/specificity) but as conformance to established safety and performance standards, and substantial equivalence to legally marketed predicate devices. The "reported device performance" is the statement of conformity.

    Acceptance Criteria (Regulatory Context)Reported Device Performance (as stated in the 510(k) Summary)
    Substantial Equivalence to Predicate Devices (similar technological characteristics, comparable safety & effectiveness, same intended uses)"DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices: Mindray DC-7 (K103583), Mindray M7 (K103677), GE Voluson E8 (K101236), Mindray DC-T6 (K110199), Sonosite M-Turbo (K101757), Siemens ACUSON S2000 (K112596), Siemens ACUSON SEQUOIA 512 (K063085), GE LOGIQ e (K102256). They have the similar technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes as the predicate devices."
    Conformance with Applicable Medical Safety Standards"DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical safety standards. This device has been designed to meet the following standards: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37, IEC 62304, IEC 62366, UL 60601-1, ISO14971, UD 2, UD 3 and ISO 10993-1."
    Quality System Compliance"The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems."
    Intended Uses are Consistent with Traditional Clinical Practices and FDA Guidelines"Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination."

    2. Sample size used for the test set and the data provenance:

    The document does not detail specific clinical studies with test sets, sample sizes, or data provenance (country, retrospective/prospective) for proving diagnostic performance. The evaluations mentioned are primarily for safety, electrical, and mechanical conformity.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    Not applicable, as no described clinical performance study with a test set requiring expert-established ground truth.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

    Not applicable.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    Not applicable. The device described is a general diagnostic ultrasound system, not an AI-powered diagnostic algorithm aiding human readers.

    6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

    Not applicable. This is a diagnostic ultrasound system, not a standalone algorithm.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

    Not applicable in the context of clinical diagnostic performance. For technical evaluations, the "ground truth" would be the specifications and requirements defined by the applicable standards (e.g., standard measures for acoustic output, material properties for biocompatibility testing).

    8. The sample size for the training set:

    Not applicable, as no described AI/algorithm training process.

    9. How the ground truth for the training set was established:

    Not applicable.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1